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Register:	CTRI
Last refreshed on:	29 April 2024
Main ID:	CTRI/2024/04/065969
Date of registration:	19-04-2024
Prospective Registration:	Yes
Primary sponsor:	Council of Science and Technology U P
Public title:	Assessing the clinical severity and treating peri-implantitis surrounding dental implants in patients who recovered from COVID-19
Scientific title:	A clinical evaluation of severity and management of peri-implantitis around dental implant in post COVID 19 patients- Randomized control trial - NIL
Date of first enrolment:	01-05-2024
Target sample size:	60
Recruitment status:	Not Yet Recruiting
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=103649
Study type:	Interventional
Study design:	Randomized, Parallel Group Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable
Phase:	Phase 3/ Phase 4

Countries of recruitment
India

Contacts

Name:	Lakshya Kumar
Address:	6th floor, Department of Prosthodontics Crown and Bridge, New Dental building, Faculty of Dental Sciences, King Georges Medical University, Lucknow 226003 Lucknow, UTTAR PRADESH India
Telephone:	9412119778
Email:	lakshya79@yahoo.com
Affiliation:	King Georges Medical University

Name:	Mayank Singh
Address:	6th floor, Department of Prosthodontics Crown and Bridge, New Dental building, Faculty of Dental Sciences, King Georges Medical University, Lucknow 226003 Lucknow, UTTAR PRADESH India
Telephone:	9412119778
Email:	lakshya79@yahoo.com
Affiliation:	King Georges Medical University

Key inclusion & exclusion criteria

Inclusion criteria: Post covid-19 healthy subjects will be recruited who have SPO2, Pulse rate, Blood pressure within standard limits.

Ability to understand the procedure and provide informed consent assessed by decision making capacity and approaches before being included in the study.

Diagnosis of peri-implantitis based on the soft tissue around the implant showing obvious inflammatory symptoms, bone loss revealed by X-ray examination and probable haemorrhage and suppuration.

At least 2 implant site with periodontal PD =4- 6 mm.

Plaque Index around the implant = 2 points

Visible bleeding around the implant after probing.

CAL = 3 mm.
Exclusion criteria: Current smoking habit with moderate or heavy smoking (more than 10 cigarettes per day) or chewing tobacco.

History of drug abuse or alcoholism within the past 5 years

Severe bruxism or clenching habit.

Significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.

History of systemic disease that precludes standard dental implant therapy.

Past history of implant repair and failure over past 6 months.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: T857- Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts

Intervention(s)

Intervention1: Mechanical debridement with adjunct laser therapy: Following mechanical debridement with the help of a sterile ultrasonic scaler and titanium curettes. After proper irrigation with the saline laser will be placed inside the gingival sulcus till the bottom slowly and left in situ for 2 minutes. After 3 minutes of placement, the peri-implant sites will be exposed to the laser for 10 s at each site.
Following this follow will be done upto 2 years.
Control Intervention1: Mechanical debridement with adjunct antimicrobial therapy: Following mechanical debridement with the help of a sterile ultrasonic scaler and titanium curettes. Patients will be given antimicrobial tetracycline gel in the peri-implant pocket depth. Post intervention follow up done upto 2 years

Primary Outcome(s)

1. Clinical evaluation of Peri-implant plaque index (PI), BOP, PPD, CAL.

2. Radiographically evaluation of Marginal bone loss.

3. Evaluation of OPG levels in Peri-implant sulcular fluid (PISF).Timepoint: Upto 2 years

Secondary Outcome(s)

1. Evaluation of implant stability by Resonance frequency test.

2. Evaluation of pink and white aesthetic score.Timepoint: Upto 2 years

Secondary ID(s)

NIL

Source(s) of Monetary Support

Department of Prosthodontics Crown and Bridge, Faculty of Dental Sciences, King Georges Medical University, Lucknow

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 18/01/2024
Contact:

King Georges Medical University Institutional Ethics Committee

Results

Results available:
Date Posted:
Date Completed:
URL:

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